Lars Björnebo, Andrea Discacciati, Ahmad Abbadi, Ugo Giovanni Falagario, Jan Chandra Engel, Hari T Vigneswaran, Fredrik Jäderling, Henrik Grönberg, Martin Eklund, Anna Lantz, Tobias Nordström
{"title":"前列腺特异性抗原密度作为前列腺癌磁共振成像筛查前的选择工具：来自STHLM3MRI随机临床试验的分析","authors":"Lars Björnebo, Andrea Discacciati, Ahmad Abbadi, Ugo Giovanni Falagario, Jan Chandra Engel, Hari T Vigneswaran, Fredrik Jäderling, Henrik Grönberg, Martin Eklund, Anna Lantz, Tobias Nordström","doi":"10.1016/j.euf.2025.06.008","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objective: </strong>Prostate cancer screening is challenged by overdetection, overtreatment, and high resource use. Prostate-specific antigen (PSA) density (PSAD) correlates more strongly with clinically significant cancer than PSA alone. We compare outcomes using various PSAD cutoffs to select men for magnetic resonance imaging (MRI).</p><p><strong>Methods: </strong>STHLM3MRI is a screening-by-invitation trial with 49 118 men invited and 12 750 screened. In the experimental arm, participants with elevated PSA (≥3 ng/ml) had MRI and, if positive [PI-RADS] score ≥3), systematic and targeted biopsies. Evaluated PSAD cutoffs were 0.075, 0.10, 0.125, and 0.15 ng/ml<sup>2</sup>. Prostate volume was measured by MRI or transrectal ultrasound. The primary endpoint was Gleason ≥3 + 4 cancer detection. The secondary endpoints were Gleason 6 and ≥4 + 3 cancer detection, and the number of MRI scans and biopsies. Relative positive fractions (RPFs) compared the outcomes using PSA ≥3 ng/ml alone.</p><p><strong>Key findings and limitations: </strong>Of 7609 men in the experimental arm, 929 (12.2%) had PSA ≥3 ng/ml, and 846 (91%) underwent MRI, with 38% having a PI-RADS score of ≥3. The median prostate volume was 45 ml (interquartile range [IQR], 33-62 ml) and PSAD 0.10 ng/ml<sup>2</sup> (IQR, 0.07-0.14 ng/ml<sup>2</sup>). A PSAD cutoff of 0.075 ng/ml<sup>2</sup> reduced Gleason 6 cancer detection by 17% (RPF, 0.83; 95% confidence interval [CI], 0.72-0.96), lowered MRI use by 28% (RPF, 0.72; 95% CI, 0.69-0.75), and missed 5% (RPF, 0.95; 95% CI, 0.92-0.98) of Gleason ≥3 + 4 cancer cases, with no difference in Gleason ≥4 + 3 cancer detection. Higher PSAD thresholds reduced Gleason 6 cancer detection and MRI use, but lowered Gleason ≥3 + 4 cancer detection. Limitations include assumed equivalency between MRI and ultrasound volume.</p><p><strong>Conclusions and clinical implications: </strong>The use of PSAD before MRI lowers overdiagnosis and resource use, while maintaining detection of significant cancer cases. Our results suggest that a PSAD cutoff above 0.075 ng/ml<sup>2</sup> is not advisable, regardless of age, due to the increased risk of missing cancer cases with Gleason scores ≥3 + 4.</p>","PeriodicalId":12160,"journal":{"name":"European urology focus","volume":" ","pages":""},"PeriodicalIF":5.6000,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Prostate-specific Antigen Density as a Selection Tool Before Magnetic Resonance Imaging in Prostate Cancer Screening: An Analysis from the STHLM3MRI Randomized Clinical Trial.\",\"authors\":\"Lars Björnebo, Andrea Discacciati, Ahmad Abbadi, Ugo Giovanni Falagario, Jan Chandra Engel, Hari T Vigneswaran, Fredrik Jäderling, Henrik Grönberg, Martin Eklund, Anna Lantz, Tobias Nordström\",\"doi\":\"10.1016/j.euf.2025.06.008\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and objective: </strong>Prostate cancer screening is challenged by overdetection, overtreatment, and high resource use. Prostate-specific antigen (PSA) density (PSAD) correlates more strongly with clinically significant cancer than PSA alone. We compare outcomes using various PSAD cutoffs to select men for magnetic resonance imaging (MRI).</p><p><strong>Methods: </strong>STHLM3MRI is a screening-by-invitation trial with 49 118 men invited and 12 750 screened. In the experimental arm, participants with elevated PSA (≥3 ng/ml) had MRI and, if positive [PI-RADS] score ≥3), systematic and targeted biopsies. Evaluated PSAD cutoffs were 0.075, 0.10, 0.125, and 0.15 ng/ml<sup>2</sup>. Prostate volume was measured by MRI or transrectal ultrasound. The primary endpoint was Gleason ≥3 + 4 cancer detection. The secondary endpoints were Gleason 6 and ≥4 + 3 cancer detection, and the number of MRI scans and biopsies. Relative positive fractions (RPFs) compared the outcomes using PSA ≥3 ng/ml alone.</p><p><strong>Key findings and limitations: </strong>Of 7609 men in the experimental arm, 929 (12.2%) had PSA ≥3 ng/ml, and 846 (91%) underwent MRI, with 38% having a PI-RADS score of ≥3. The median prostate volume was 45 ml (interquartile range [IQR], 33-62 ml) and PSAD 0.10 ng/ml<sup>2</sup> (IQR, 0.07-0.14 ng/ml<sup>2</sup>). A PSAD cutoff of 0.075 ng/ml<sup>2</sup> reduced Gleason 6 cancer detection by 17% (RPF, 0.83; 95% confidence interval [CI], 0.72-0.96), lowered MRI use by 28% (RPF, 0.72; 95% CI, 0.69-0.75), and missed 5% (RPF, 0.95; 95% CI, 0.92-0.98) of Gleason ≥3 + 4 cancer cases, with no difference in Gleason ≥4 + 3 cancer detection. Higher PSAD thresholds reduced Gleason 6 cancer detection and MRI use, but lowered Gleason ≥3 + 4 cancer detection. Limitations include assumed equivalency between MRI and ultrasound volume.</p><p><strong>Conclusions and clinical implications: </strong>The use of PSAD before MRI lowers overdiagnosis and resource use, while maintaining detection of significant cancer cases. Our results suggest that a PSAD cutoff above 0.075 ng/ml<sup>2</sup> is not advisable, regardless of age, due to the increased risk of missing cancer cases with Gleason scores ≥3 + 4.</p>\",\"PeriodicalId\":12160,\"journal\":{\"name\":\"European urology focus\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":5.6000,\"publicationDate\":\"2025-07-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European urology focus\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.euf.2025.06.008\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European urology focus","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.euf.2025.06.008","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
Prostate-specific Antigen Density as a Selection Tool Before Magnetic Resonance Imaging in Prostate Cancer Screening: An Analysis from the STHLM3MRI Randomized Clinical Trial.
Background and objective: Prostate cancer screening is challenged by overdetection, overtreatment, and high resource use. Prostate-specific antigen (PSA) density (PSAD) correlates more strongly with clinically significant cancer than PSA alone. We compare outcomes using various PSAD cutoffs to select men for magnetic resonance imaging (MRI).
Methods: STHLM3MRI is a screening-by-invitation trial with 49 118 men invited and 12 750 screened. In the experimental arm, participants with elevated PSA (≥3 ng/ml) had MRI and, if positive [PI-RADS] score ≥3), systematic and targeted biopsies. Evaluated PSAD cutoffs were 0.075, 0.10, 0.125, and 0.15 ng/ml2. Prostate volume was measured by MRI or transrectal ultrasound. The primary endpoint was Gleason ≥3 + 4 cancer detection. The secondary endpoints were Gleason 6 and ≥4 + 3 cancer detection, and the number of MRI scans and biopsies. Relative positive fractions (RPFs) compared the outcomes using PSA ≥3 ng/ml alone.
Key findings and limitations: Of 7609 men in the experimental arm, 929 (12.2%) had PSA ≥3 ng/ml, and 846 (91%) underwent MRI, with 38% having a PI-RADS score of ≥3. The median prostate volume was 45 ml (interquartile range [IQR], 33-62 ml) and PSAD 0.10 ng/ml2 (IQR, 0.07-0.14 ng/ml2). A PSAD cutoff of 0.075 ng/ml2 reduced Gleason 6 cancer detection by 17% (RPF, 0.83; 95% confidence interval [CI], 0.72-0.96), lowered MRI use by 28% (RPF, 0.72; 95% CI, 0.69-0.75), and missed 5% (RPF, 0.95; 95% CI, 0.92-0.98) of Gleason ≥3 + 4 cancer cases, with no difference in Gleason ≥4 + 3 cancer detection. Higher PSAD thresholds reduced Gleason 6 cancer detection and MRI use, but lowered Gleason ≥3 + 4 cancer detection. Limitations include assumed equivalency between MRI and ultrasound volume.
Conclusions and clinical implications: The use of PSAD before MRI lowers overdiagnosis and resource use, while maintaining detection of significant cancer cases. Our results suggest that a PSAD cutoff above 0.075 ng/ml2 is not advisable, regardless of age, due to the increased risk of missing cancer cases with Gleason scores ≥3 + 4.
期刊介绍：
European Urology Focus is a new sister journal to European Urology and an official publication of the European Association of Urology (EAU).
EU Focus will publish original articles, opinion piece editorials and topical reviews on a wide range of urological issues such as oncology, functional urology, reconstructive urology, laparoscopy, robotic surgery, endourology, female urology, andrology, paediatric urology and sexual medicine. The editorial team welcome basic and translational research articles in the field of urological diseases. Authors may be solicited by the Editor directly. All submitted manuscripts will be peer-reviewed by a panel of experts before being considered for publication.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
